Field Of The Invention
Pulmonary function testing equipment, such as spirometers, lung analyzers, etc., assess lung capacity by measuring and/or analyzing the flow, volume, and specific composition of expired gases. These tests and certain associated parameters have been standardized by The American Thoracic Society (ATS). ATS has developed a list of mechanical factors for each test which must be met in order to ensure continuity of testing and test results Ventilation equipment, such as respirators and ventilators, also depends on specific air flows and volumes to operate effectively.
Both testing equipment and treatment equipment require simultaneous fluid connection to the equipment and the patient's mouth, or the vicinity of the mouth. An exhaled breath is composed of dry and humidified gases which provide a medium for bacterial and viral transfer that could contaminate such equipment. Additionally, the patient may be salivating, or separate rubber or cardboard mouthpieces used in pulmonary function testing can stimulate the production of saliva, which then drips, or flows, into equipment components. Therefore, there is a risk of contamination of equipment components from microorganisms borne in saliva as well as expired gas. In the absence of an effective filter, bacteria and viruses can be deposited on the equipment. If testing or treatment equipment were to become contaminated, subsequent patients would be at risk of contacting many diseases, including, but not limited to tuberculosis, pneumocystis carinii pneumonia, HIV, hepatitis, herpes, and the common cold.
The inconvenience and expense of sterilizing equipment components between patients severely limits, in practice, the number of medical professionals who actually sterilize such equipment after each patient. Until recently, medical professionals assumed that a disposable cardboard mouthpiece, or clean rubber mouthpiece, was adequate protection from cross-contamination. In the current environment of drug resistent bacterial and viral strains, there is a growing awareness of the need for adequate, low cost protection.